Afinitor medicine 10mg Everolimus treatment for breast cancer

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Afinitor medicine 10mg Everolimus treatment for breast cancer

• Drug name: Afinitor 10mg
• Active ingredient: Everolimus
• Content: 10mg
• Tablets: Tablets
• Package: 1 box of 30 tablets

Indications Afinitor 10mg everolimus

Afinitor tablets are indicated for the treatment of:

• In combination with exemestane for postmenopausal women with advanced breast cancer positive hormone receptor, HER2 / neu negative, after relapse or progression without symptomatic and metastatic internal metastasis Previous treatment with a nonsteroidal aromatase inhibitor.
• Adult patient with advanced pancreatic origin neuropathy, good or moderate differentiation, inoperable or metastatic.
• Patients with renal cell carcinoma progresses far further with the disease progressing during treatment or after treatment with VEGF-targeted drugs.

Dosage and Administration of Afinitor

Dosage of afinitor drugs

Afinitor treatment should be started by a doctor who has experience in using anti-cancer therapies.

Treatment should be continued as long as the clinical benefit is still recognized or until an unacceptable toxicity occurs.

Target group in general

Doses in advanced breast cancer with positive hormone receptors, advanced neuro-endocrine tumors originating in the pancreas and advanced renal cell carcinoma:

The recommended dose of Afinitor is 10 mg orally once daily

Change the dose during the use of afinitor drug

Adverse reactions when using afinitor drugs

The management of severe or intolerable drug (ADR) adverse reactions may require suspension (with or without dose reduction) or complete discontinuation of Afinitor treatment. If dose reduction is required, the recommended dose is approximately 50% lower than the previous daily dose. For reducing the dose below the lowest available tablet content, it is advisable to consider dosing every other day.

Table 1 summarizes recommendations for stopping, reducing, or stopping Afinitor treatment in the management of adverse drug reactions, including general management recommendations when appropriate. The clinical evaluation of the treating physician will guide the management plan for each patient based on a benefit-risk assessment for each patient.

Table 1 Recommended dose adjustment Afinitor and management of adverse drug reactions

Adverse reactions of the drug Severe1 Recommended dose adjustment Afinitor2 and management

Non-bacterial pneumonia Grade 1

• No symptoms, signs on x-ray film No dose adjustment required.
• Start tracking appropriately.

Grade 2

• Symptomatic, does not interfere with ADL3
• Consider discontinuing treatment, eliminate infections, and consider treatment with corticosteroids until symptoms improve to ≤ grade 1.
• Start using Afinitor again at a lower dose.
• Discontinue treatment if no recovery within 4 weeks.

Grade 3

• Symptomatic, interfering with ADL3 indicates O2 breathing
• Discontinue Afinitor, eliminate infections and consider treatment with corticosteroids until symptoms subside to ≤ 1 degree.
• Consider starting Afinitor again at a lower dose.
• If relapse toxicity is at grade 3, treatment should be discontinued.

Grade 4

• Life-threatening, indicated for respiratory assistance. Discontinue Afinitor, eliminate infections and consider treatment with corticosteroids.

Stomatitis Grade 1

• Minimal symptoms, normal diet No need to adjust the dose.
• Treat with non-alcoholic mouthwash or salt water (0.9%) several times a day.

Grade 2

• Symptoms but can eat and swallow modified diet
• Suspension of dose until recovery to level 1.
• Start taking Afinitor again at the same dose.
• If recurrent stomatitis 2, discontinue the dose until recovery to level 1. Start using Afinitor again with a lower dose.
• Treatment with topical mouth pain treatments (e.g., benzocaine, butyl aminobenzoate, tetracaine hydrochloride, methol or phenol), with or without topical corticosteroids (i.e. triamcinolone oral ointment) .4

Grade 3

• Symptomatic and unable to eat or drink by mouth
• Suspension of dose until recovery to level 1.
• Start using Afinitor again at a lower dose.
• Manage with topical mouth pain treatments (i.e. benzocaine, butyl aminobenzoate, tetracaine hydrocholoride, methol or phenol) with or without topical corticosteroids (i.e. triamcinolone oral ointment) .4

Grade 4

• Have life-threatening symptoms Stop Afinitor completely and manage with appropriate medical treatment.

Other toxicity is not hematologic (except for metabolic events)

Grade 1

• If the toxicity is tolerable, no dose adjustment is necessary.
• Start appropriate medical treatment and follow up.

Grade 2

• If the toxicity is tolerable, no dose adjustment is necessary.
• Start appropriate medical treatment and follow up.
• If toxicity becomes intolerable, discontinue the drug until recovery to level 1. Start Afinitor again at the same dose.
• If toxicity recurs at grade 2, suspend Afinitor until recovery to level 1. Start Afinitor again at a lower dose.

Grade 3

• Suspend the dose until recovering to  degree 1.
• Start appropriate medical treatment and follow up.
• Consider starting Afinitor again at a lower dose.
• If relapse toxicity is at grade 3, treatment should be discontinued.

Grade 4

• Discontinue Afinitor and manage with appropriate medical treatment.

Metabolic events (e.g. hyperglycemia, dyslipidemia)

Grade 1 No dose adjustment is needed.

• Start appropriate medical treatment and follow up.

Grade 2

• No dose adjustment is needed.
• Manage with appropriate medical treatment and monitoring.

Grade 3 Suspension dose .

• Start using Afinitor again at a lower dose.
• Manage with appropriate medical treatment and monitoring.

Grade 4

• Discontinue Afinitor and manage with appropriate medical treatment.
• 1 Severity description: 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms; 4 = life-threatening symptoms.
• 2 If the dose needs to be reduced, the recommended dose is about 50% of the previous daily dose
• 3 Daily activities
• 4 Avoid using alcohol, hydrogen peroxide, iodine and thyme derivatives in the management of stomatitis as these can worsen mouth ulcers.

Medium inhibitor of CYP3A4 or P-glycoprotein (PgP)

Caution should be exercised when used in combination with an average inhibitor of CYP3A4 or PgP. If patients need to use in combination with an average CYP3A4 or PgP inhibitor, reduce the Afinitor dose to about 50% of the previous daily dose. Further reductions may be needed to control adverse drug reactions. For reducing the dose below the lowest available Afinitor content, it is advisable to consider taking the drug every other day. Additional doses may be required to address adverse drug reactions.

Positive breast cancer with a positive hormone receptor, advanced endocrine neuropathy originating in the pancreas, advanced renal cell carcinoma the period of elimination is at least 2 to 3 days (the average time for the most common average inhibitors) before an increase in Afinitor dose. The Afinitor dose may return to the previous dose level at the start of the average CYP3A4 / PgP inhibitor use.

Strong inducers CYP3A4

Avoid using Afinitor together with strong inducers CYP3A4.

Positive breast cancer has a positive hormone receptor, advanced endocrine neuropathy originating in the pancreas, advanced kidney cell carcinoma: If the patient needs to be used in combination with a strong inducers CYP3A4, weigh remind to double the daily dose of Afinitor (based on pharmacokinetic data) by no more than 5 mg per dose increase. Predict this dose of Afinitor will adjust the area under the curve (AUC) to the range of no inducers. However, there are no clinical data on dose adjustments in patients receiving potent CYP3A4 inducers.

Dosage of Afinitor in special patient group

Child patient group

• Afinitor is not recommended for pediatric patients with cancer.

Elderly patients (≥ 65 years)

• No dose adjustment is needed.

CKD

• No dose adjustment is needed.

Liver failure

• Positive breast cancer has a positive hormone receptor, advanced endocrine neuropathy originating in the pancreas, and advanced kidney cell carcinoma:
  • Mild hepatic impairment (Child-Pugh A) – the recommended dose is 7.5 mg / day
  • Moderate liver failure (Child-Pugh B) – the recommended dose is 5 mg / day, which can be reduced to a dose of 2.5 mg if not well tolerated.
  • Severe hepatic impairment (Child-Pugh C) – not recommended for use. If the desired benefits outweigh the risks, the dose should not exceed 2.5 mg / day.

Dose adjustment is necessary if the patient’s liver (Child-Pugh) status changes during treatment.

How to use Afinitor 10mg

• Afinitor is taken once a day at the same time, with or without food.
• Afinitor tablets should be swallowed whole with a glass of water. Do not chew or crush.
• For patients who cannot swallow the tablet completely, dissolve the Afinitor completely in a glass of water (containing about 30 mL) by stirring gently until the tablet dissolves (about 7 minutes), immediately before taking. The glass should be rinsed with the same amount of water and swallowed whole amount of rinsed water to make sure to take the entire dose.

Anti-Action Drugs Afinitor 10mg

• Afinitor is contraindicated in patients with hypersensitivity to the active substance, to other rapamycin derivatives or to any component of excipients.

Warnings and precautions when using Afinitor

Read the instructions carefully before use. If you need further information, please consult your doctor.

This medicine is for prescription only.

Non-bacterial pneumonia

• Non-bacterial pneumonia is an effect of the group of rapamycin derivatives. Cases of non-bacterial pneumonia (including interstitial lung disease) have also been described in Afinitor patients. Some of these cases were severe and in very rare cases the death record was recorded.
• The diagnosis of non-bacterial pneumonia should be considered in patients with non-specific respiratory signs and symptoms such as tissue hypoxia, pleural effusion, coughing or shortness of breath and in those whose causes of infection, Neoplasia tumors and other non-pharmacologic causes were excluded by appropriate tests. Differential diagnosis is needed to exclude opportunistic infections such as pneumocystis jirovecii pneumonia (PJP: pneumocystis jirovecii pneumonia) when diagnosing non-bacterial pneumonia (see section Infection).
• Patients should be advised to immediately report any new or worsening respiratory symptoms.
• For patients who have radiological changes that suggest non-bacterial pneumonia and have few or no symptoms, treatment with Afinitor can be continued without changing the dose.
• If symptoms are moderate (grade 2), treatment should be discontinued until symptoms improve. May appoint corticosteroid use. Afinitor can be reused with daily doses reduced to about 50% of previous doses.
• In cases of non-bacterial grade 3 pneumonia, treatment with Afinitor must be discontinued until symptoms subside to grade 1 or below. Afinitor can be reused with a dose reduced to about 50% of the previous dose, depending on the clinical condition of each patient. If toxicity recurs at grade 3, then consider stopping Afinitor completely. For cases of pneumonia level 4 non-bacterial infection, Afinitor should be completely stopped. Corticosteroids may be indicated until the clinical symptoms clear up.
• Pneumocystis jirovecii (PJP) prevention should be considered for patients who must be treated with non-bacterial pneumonia with corticosteroids.
• Occurrence of pneumonia has also been reported at reduced dose levels.

Infection

• Afinitor has immunosuppressive properties and can make patients susceptible to bacterial, fungal, viral or unicellular infections including infections caused by opportunistic pathogens. Local and systemic infections include pneumonia, other infections, invasive fungal infections such as Aspergillus, Candida, or pneumocystis jirovecii (PJP) and viral infections including reactivation of the viral virus Hepatitis B has been described in patients taking Afinitor. Some of these infections are severe (for example, lead to sepsis, respiratory failure or liver failure) and sometimes result in death.
• Doctors and patients should be aware of the increased risk of infection when taking Afinitor. Before starting treatment with Afinitor, pre-existing infections should be managed. During treatment with Afinitor, be alert for signs and symptoms of infection; If an infection has been diagnosed, appropriate treatment should be carried out immediately and consideration should be given to discontinuing or discontinuing treatment with Afinitor.
• If invasive fungal infection has been diagnosed, Afinitor should be stopped and managed with appropriate antifungal therapy.
• Cases of everolimus-treated patients who died from pneumocystis jirovecii pneumonia have been reported. Pneumocystis jirovecii pneumonia may be associated with concomitant administration of everolimus with corticosteroids or immunosuppressive drugs. Consider pneumocystis jirovecii pneumonia when it is necessary to use everolimus concomitantly with corticosteroids or other immunosuppressive drugs.

Hypersensitivity reactions

• Hypersensitivity reactions manifested by symptoms include, but are not limited to, anaphylaxis, dyspnea, flushing, chest pain or angioedema (e.g. airway or tongue edema, with or without Respiratory depression) has been observed with everolimus.
• Angioedema due to concomitant use of everolimus and angiotensin converting enzyme inhibitors (ACE: Angiotensin-converting enzyme)
• Patients treated with everolimus concomitantly with ACE inhibitors may increase the risk of angioedema (e.g., respiratory edema or tongue may or may not be accompanied by respiratory failure).

Mouth sores

• Oral ulcers, stomatitis and oral mucositis have been reported in patients treated with Afinitor. In these cases, it is recommended to use topical treatments but avoid mouthwashes containing alcohol, hydrogen peroxide, iodine, or thyme, as these can make the condition worse. Antifungal drugs should not be used unless a fungal infection has been diagnosed.

Cases of renal failure

• In cases of renal failure (including acute renal failure), a number of fatal outcomes have been observed in Afinitor-treated patients. Special renal function should be monitored in patients with additional risk factors that may lead to impaired renal function. (see section Testing and monitoring).
• Testing and monitoring

Renal function

• Increased serum creatinine, usually mild and proteinuria has been reported in patients using Afinitor. Monitoring of renal function is recommended, including measurement of blood urea nitrogen (BUN), proteinuria or serum creatinine before initiation of Afinitor therapy and subsequent periodic monitoring.

Blood glucose

• Hyperglycemia has been reported in patients using Afinitor. It is recommended to monitor fasting serum glucose before starting Afinitor treatment and periodically thereafter. Recommended for more frequent monitoring when Afinitor is taken concomitantly with other drugs that may increase blood glucose. Optimal glucose control should be achieved before initiating Afinitor treatment for patients.

Blood lipids

• Abnormal blood lipids (including hypercholesterolemia and hypertriglyceridemia) have been reported in patients using Afinitor. It is recommended to monitor blood cholesterol and blood triglycerides before starting Afinitor treatment and periodically thereafter as well as control with appropriate medical therapy.

Hematological parameters

• There have been reports of decreased hemoglobin, lymphocytes, platelets and neutrophils in patients taking Afinitor. It is recommended to monitor whole blood count before starting Afinitor treatment and follow up periodically thereafter.

Afinitor drug interactions

• Avoid use in combination with strong inhibitors of CYP3A4 or PgP.
• Use with caution in combination with CYP3A4 inhibitors or moderate PgP inhibitors. If Afinitor is used in combination with an CYP3A4 inhibitor or a medium PgP inhibitor, patients should be carefully monitored for undesirable effects and a dose reduction of Afinitor if necessary.
• Avoid use in combination with strong inducers CYP3A4 or PgP. If a combination of Afinitor and a strong inducers CYP3A4 or PgP is used, patients should be carefully monitored for clinical response. Consider increasing Afinitor dose when used in combination with a strong CYP3A4 or PgP inducer if alternative treatment is not available
• Due to the potential for drug interactions, caution should be exercised when using Afinitor in combination with substrates of CYP3A4 orally with a narrow therapeutic index. If Afinitor is taken with CYP3A4 substrates orally with a narrow therapeutic index, patient monitoring is needed to detect undesirable effects described in the product information section of CYP3A4 substrates. to drink.

Liver failure

• Everolimus levels are increased in patients with mild hepatic impairment (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C).
• Afinitor is not recommended in patients with severe hepatic impairment (Child-Pugh C) for the treatment of advanced hormone receptor-positive breast cancer in postmenopausal women, advanced neuroendocrine tumors. In pancreatic radicals, renal cell carcinoma progresses unless the expected benefits outweigh the risks

Immunization

• Live vaccines should be avoided and close contact with people who have been vaccinated live during Afinitor treatment.

Lactose

• Patients with rare inherited galactose intolerance or Lapp lactase deficiency or glucose – galactose malabsorption should not use this medication.

Complications of healing wounds injured

• The healing process is affected by rapamycin derivatives, including Afinitor. Caution should be exercised when using Afinitor during the perioperative period.
• Carcinoid tumors: the efficacy and safety of Afinitor have not been established in patients with carcinoid tumors.

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